Study of the Efficacy and Safety of Ruxolitinib to Treat COVID-19 Pneumonia

Sponsor
University Health Network, Toronto (Other)
Overall Status
Terminated
CT.gov ID
NCT04331665
Collaborator
(none)
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Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety and efficacy of the drug ruxolitinib in people diagnosed with COVID-19 pneumonia by determining the number of people whose conditions worsen (requiring machines to help with breathing or needing supplemental oxygen) while receiving the drug.

This is a sub-study of the U-DEPLOY study: UHN Umbrella Trial Defining Coordinated Approach to Pandemic Trials of COVID-19 and Data Harmonization to Accelerate Discovery. U-DEPLOY helps to facilitate timely conduct of studies across the University Health Network and other centers.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Multifocal interstitial pneumonia is the most common cause of deterioration in people with COVID-19. This is attributed to a severe reaction where releases too many cytokines (proteins that play an important role in immune responses) which rush into the lungs resulting in lung inflammation and fluid buildup. This can lead to damage to the lungs and leading to breathing problems. Ruxolitinib when given early in the disease, may prevent the overproduction of cytokines which, in turn, may prevent lung damage.

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Arm Open-label Clinical Study to Investigate the Efficacy and Safety of Ruxolitinib for the Treatment of COVID-19 Pneumonia
Actual Study Start Date :
May 21, 2020
Actual Primary Completion Date :
Jan 5, 2021
Actual Study Completion Date :
Mar 24, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ruxolitinib to prevent COVID-19 pneumonia

All participants will receive ruxolitinib at at 10 mg, twice a day, for 14 days, followed by 5 mg, twice a day, for 2 days and 5 mg, once daily, for 1 day.

Drug: Ruxolitinib
Ruxolitinib is an inhibitor of JAK1 and JAK2 (proteins important in cell signalling) approved for the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease.
Other Names:
  • JAKAVI
  • Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients with COVID-19 pneumonia who become critically ill (defined as requiring mechanical ventilation and/or FiO2 of 60% of more) [6 months]

    2. Number of adverse events [9 months]

    Secondary Outcome Measures

    1. All cause mortality rate [9 months]

    2. Average duration of hospital stay [9 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • COVID-19 infection diagnosed by nasopharyngeal sample

    • Need for supplemental oxygen to maintain oxygen saturation > 93%

    • 12 years of age or older

    Exclusion Criteria:
    • Neutrophils < 1 x 10^9/L

    • Platelets < 50 x 10^9/L

    • Serum total bilirubin >2.0 x upper limit of normal (ULN)

    • Aspartate aminotransferase (AST), or alanine aminotransferase (ALT) > 5x ULN

    • Creatinine clearance (CrCl) < 15 mL/minute

    • Pregnant women

    • Known HBV or HIV infection

    • Signs and symptoms of Varicella Zoster Virus (VZV) infection

    • Patients requiring invasive mechanical ventilation. Patients requiring non-invasive mechanical ventilation (e.g., BiPAP) are eligible.

    • Patients who require supplemental oxygen support prior to COVID-19 infection.

    • Patients who are on ruxolitinib or similiar drugs.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Princess Margaret Cancer Centre Toronto Ontario Canada M5G 2M9

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    • Principal Investigator: Steven Chan, M.D., Princess Margaret Cancer Centre
    • Principal Investigator: Vikas Gupta, M.D., Princess Margaret Cancer Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT04331665
    Other Study ID Numbers:
    • U-DEPLOY: RUX-COVID
    • 20-5315
    First Posted:
    Apr 2, 2020
    Last Update Posted:
    Aug 19, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 19, 2021